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Name /bks_53161_deglins_md_disk/topiramate 03/17/2014 11:32AM 1 Plate # 0-Composite pg 1 # 1 Topamax, Trokendi XR Classification Therapeutic: anticonvulsants, mood stabilizers Pregnancy Category D Use Cautiously in: All patients (mayqrisk of suicidal thoughts/behaviors); Renal impairment (dose reduction recommended if CCr ⬍70 mL/min/1.73 m2); Hepatic impairment; Dehydration; Patients predisposed to metabolic acidosis; Patients allergic to sulfa; OB: Mayqrisk for cleft palate and/or cleft lip in infants exposed during pregnancy; use only if maternal benefit outweighs fetal risk; Pedi: Children are more prone to oligohydrosis and hyperthermia; safety in children ⬍2 yr (immediate-release) and ⬍6 yr (extended-release) not established (; Geri: Consider age-relatedp in renal/hepatic impairment, concurrent disease states and drug therapy. Indications Adverse Reactions/Side Effects CNS:qSEIZURES, SUICIDAL THOUGHTS, dizziness, drowsiness, fatigue, impaired con- topiramate (toe-peer-i-mate) Seizures including: partial-onset, primary generalized tonic-clonic, seizures due to Lennox-Gastaut syndrome. Prevention of migraine headache in adults (immediaterelease only). Unlabeled Use: Adjunct in treatment of bipolar disorder. Infantile spasms. Action Action may be due to: Blockade of sodium channels in neurons, Enhancement of gamma-aminobutyrate (GABA), an inhibitory neurotransmitter, Prevention of activation of excitatory receptors. Therapeutic Effects: Decreased incidence of seizures. Decreased incidence/severity of migraine headache. Pharmacokinetics Absorption: Well absorbed (80%) after oral administration. Distribution: Unknown. Metabolism and Excretion: 70% excreted unchanged in urine. Half-life: 21 hr; Extended-release— 31 hr. TIME/ACTION PROFILE (blood levels†) ROUTE ONSET PEAK DURATION PO PO-ER unknown unknown 2 hr 24 hr 12 hr unknown †After single dose Contraindications/Precautions Contraindicated in: Hypersensitivity; Recent alcohol use (within 6 hr before and after use of extended-release product); Metabolic acidosis (on metformin) (with extended-release product only); Lactation: Lactation. ⫽ Canadian drug name. ⫽ Genetic Implication. centration/memory, nervousness, psychomotor slowing, speech problems, sedation, aggressive reaction, agitation, anxiety, cognitive disorders, confusion, depression, malaise, mood problems. EENT: abnormal vision, diplopia, nystagmus, acute myopia/secondary angle closure glaucoma. GI: nausea, abdominal pain, anorexia, constipation, dry mouth, encephalopathy, hyperammonemia. GU: kidney stones. Derm: oligohydrosis (qin children). F and E: hyperchloremic metabolic acidosis. Hemat: leukopenia. Metab: weight loss, hyperthermia (qin children). Neuro: ataxia, paresthesia, tremor. Misc: fever. Interactions Drug-Drug: Alcohol use within 6 hr before or after use of extended-release product may significantly alter topiramate levels; use during this time frame contraindicated. Levels and effects may bepby phenytoin, carbamazepine, or valproic acid. Mayqlevels and effects of phenytoin, amitriptyline, or lithium . Mayplevels and effects of hormonal contraceptives, risperidone, or valproic acid.q risk of CNS depression with alcohol or other CNS depressants. Carbonic anhydrase inhibitors (e.g. acetazolamide or zonisamide) mayqrisk of metabolic acidosis and kidney stones. Concurrent use with valproic acid mayqrisk of hyperammonemia, encephalopathy, and hypothermia. Route/Dosage Epilepsy (monotherapy) PO (Adults and children ⱖ10 yr): Immediate-release— 25 mg twice daily initially, graduallyqat weekly intervals to 200 mg twice daily over a 6– wk period; Extended-release— 50 mg once daily initially, graduallyqat weekly intervals to 400 mg once daily over a 6– wk period. CAPITALS indicate life-threatening, underlines indicate most frequent. Strikethrough ⫽ Discontinued. PDF Page #1 Name /bks_53161_deglins_md_disk/topiramate 03/17/2014 11:32AM 2 PO (Children 2– ⬍10 yr and ⱕ11 kg): Immediate-release— 25 mg once daily in the evening initially, graduallyqat weekly intervals to 75 mg twice daily over a 5-7– wk period; if needed may continue to titrate dose on a weekly basis up to 125 mg twice daily. PO (Children 2– ⬍10 yr and 12– 22 kg): Immediate-release— 25 mg once daily in the evening initially, graduallyqat weekly intervals to 100 mg twice daily over a 5-7– wk period; if needed may continue to titrate dose on a weekly basis up to 150 mg twice daily. PO (Children 2– ⬍10 yr and 23– 31 kg): Immediate-release— 25 mg once daily in the evening initially, graduallyqat weekly intervals to 100 mg twice daily over a 5-7– wk period; if needed may continue to titrate dose on a weekly basis up to 175 mg twice daily. PO (Children 2– ⬍10 yr and 32– 38 kg): Immediate-release— 25 mg once daily in the evening initially, graduallyqat weekly intervals to 125 mg twice daily over a 5-7– wk period; if needed may continue to titrate dose on a weekly basis up to 175 mg twice daily. PO (Children 2– ⬍10 yr and ⬎38 kg): Immediate-release— 25 mg once daily in the evening initially, graduallyqat weekly intervals to 125 mg twice daily over a 57– wk period; if needed may continue to titrate dose on a weekly basis up to 200 mg twice daily. Renal Impairment PO (Adults): CCr⬍70 mL/min—pdose by 50%. Epilepsy (adjunctive therapy) PO (Adults and Children ⱖ17 yr): Immediate-release— 25– 50 mg/day initially,qby 25– 50 mg/day at weekly intervals up to 200– 400 mg/day in 2 divided doses (200– 400 mg/day in 2 divided doses for partial seizures or Lennox-Gastaut syndrome and 400 mg/day in 2 divided doses for primary generalized tonic-clonic seizures); Extended-release— 25– 50 mg once daily initially,qby 25– 50 mg/day at weekly intervals up to 200– 400 mg once daily (for partial seizures or Lennox-Gastaut syndrome) and 400 mg once daily (for primary generalized tonic-clonic seizures). PO (Children 2– 16 yr): Immediate-release— 25 mg once daily at night initially for first wk,qat 1– 2 wk intervals by 1– 3 mg/kg/day up to 5– 9 mg/kg/day in 2 divided doses. Plate # 0-Composite pg 2 # 2 PO (Children 6– 16 yr): Extended-release— 25 mg once daily at night initially for first wk,qat 1– 2 wk intervals by 1– 3 mg/kg/day up to 5– 9 mg/kg/day given once daily at night. Renal Impairment PO (Adults): CCr⬍70 mL/min—pdose by 50%. Migraine prevention PO (Adults): 25 mg at night initially,qby 25 mg/day at weekly intervals up to target dose of 100 mg/day in 2 divided doses. Renal Impairment PO (Adults): CCr⬍70 mL/min—pdose by 50%. NURSING IMPLICATIONS Assessment ● Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. ● Seizures: Assess location, duration, and characteristics of seizure activity. ● Migraines: Assess pain location, intensity, duration, and associated symptoms (photophobia, phonophobia, nausea, vomiting) during migraine attack. Monitor frequency and intensity of pain on pain scale. ● Bipolar Disorder: Assess mental status (mood, orientation, behavior) and cognitive abilities before and periodically during therapy. ● Lab Test Considerations: Monitor CBC with differential and platelet count before therapy to determine baseline levels and periodically during therapy. Frequently causes anemia. ● Hepatic function should be monitored periodically throughout therapy. May cause qAST and ALT levels. ● Evaluate serum bicarbonate prior to and periodically during therapy. If metabolic acidosis occurs, dosing taper or discontinuation may be necessary. Potential Nursing Diagnoses Risk for injury (Indications) (Side Effects) Disturbed thought process (Indications) Implementation ● Implement seizure precautions. ● Do not confuse Topamax (topiramate) with Toprol XL (metoprolol). 䉷 2015 F.A. Davis Company CONTINUED PDF Page #2 Name /bks_53161_deglins_md_disk/topiramate 03/17/2014 11:32AM Plate # 0-Composite ● Advise patient and family to notify health care professional if thoughts 3 CONTINUED topiramate ● PO: May be administered without regard to meals. ● Do not break/crush tablets because of bitter taste. ● Contents of the sprinkle capsules can be sprinkled on a small amount (teaspoon) of soft food, such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt. To open, hold the capsule upright so that you can read the word “TOP.” Carefully twist off the clear portion of the capsule. It may be best to do this over the small portion of the food onto which you will be pouring the sprinkles. Sprinkle the entire contents of the capsule onto the food. Be sure the patient swallows the entire spoonful of the sprinkle/food mixture immediately without chewing. Follow with fluids immediately to make sure all of the mixture is swallowed. Never store a sprinkle/food mixture for use at another time. ● A 6 mg/mL oral suspension may be compounded by pharmacy for pediatric patients. ● Swallow extended-release capsules (Trokendi XR娃) whole; do not sprinkle on food, or break, crush, dissolve, or chew. Patient/Family Teaching ● Instruct patient to take topiramate exactly as directed. Take missed doses as soon ● ● ● ● pg 3 # 3 as possible but not just before next dose; do not double doses. Notify health care professional if more than 1 dose is missed. Medication should be gradually discontinued to prevent seizures and status epilepticus. Instruct patient to read the Medication Guide before starting and with each Rx refill, changes may occur. May cause decreased sweating and increased body temperature. Advise patients, especially parents of pediatric patients, to provide adequate hydration and monitoring, especially during hot weather. May cause dizziness, drowsiness, confusion, and difficulty concentrating. Caution patients to avoid driving or other activities requiring alertness until response to medication is known. Advise patient to maintain a fluid intake of 2000– 3000 mL of fluid/day to prevent the formation of kidney stones. Instruct patient to notify health care professional immediately if periorbital pain or blurred vision occur. Medication should be discontinued if ocular symptoms occur. May lead to permanent loss of vision. ⫽ Canadian drug name. ⫽ Genetic Implication. ● ● ● ● ● ● ● ● about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking, other unusual changes in behavior or mood occur. Inform patients that topiramate may cause encephalopathy. If signs and symptoms (unexplained lethargy, vomiting, changes in mental status) occur, notify health care professional. Caution patient to make position changes slowly to minimize orthostatic hypotension. Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Advise patient not to take alcohol or other CNS depressants concurrently with this medication. Avoid alcohol 6 hrs before and 6 hrs after taking Trokendi XR娃. Instruct patient to notify health care professional of medication regimen before treatment or surgery. Advise patient to use sunscreen and wear protective clothing to prevent photosensitivity reactions. Advise patient to use a nonhormonal form of contraception while taking topiramate; may make hormonal contraceptives less effective. Notify health care professional if pregnancy is planned or suspected or if breast feeding. If pregnancy occurs, encourage patient to enroll in the North American Drug Pregnancy Registry by calling 1-877-376-3872. Advise patient to carry identification describing disease and medication regimen at all times. Evaluation/Desired Outcomes ● Absence or reduction of seizure activity. ● Decrease in incidence and severity of migraine headaches. ● Remission of manic symptoms. Why was this drug prescribed for your patient? CAPITALS indicate life-threatening, underlines indicate most frequent. Strikethrough ⫽ Discontinued. PDF Page #3